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Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

Fierce Pharma

Turns out, the FDA didn’t drop the CD19 CAR-T from a classwide safety alert list. . | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

Safety 242
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Novo Nordisk, Eli Lilly face scrutiny from EU's drug regulator over GLP-1 safety

Fierce Pharma

The EMA is scrutinizing GLP-1s, raising a safety signal about the risk that drugs from Novo Nordisk, Eli Lilly and other companies could cause cancer.

Safety 295
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Medication Management Technology Puts Patient Safety at the Center of Care

MedCity News

In the same way that airbags were a natural evolution of vehicle safety technology, seamless, RFID-based systems are the next evolution of medication management technology.

Safety 101
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Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety

Fierce Pharma

Intercept's latest NASH bid in jeopardy after FDA questions drug's efficacy, safety aliu Wed, 05/17/2023 - 12:29

Safety 246
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Revvity Signals provides a centralized analytics platform built to support today’s clinical study requirements and increase trial efficiency, glean actionable analytic insights, automate data collection and harmonization, support safety and efficacy decision-making, and enable a singular view across a company’s entire candidate portfolio.

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CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices

Fierce Pharma

CDC probes possible safety risk for Pfizer's new COVID shot, sees no need to change vaccine practices. Tue, 01/17/2023 - 11:49.

Safety 321
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FDA’s Drug Safety Priorities for 2023

PharmaTech

FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.

Safety 52
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How Machine Learning Drives Clinical Trial Efficiency

Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Commercial Drug Sourcing for Clinical Trials

Sponsors can face a number of challenges when trying to obtain these critical supplies for their studies, including addressing product lead times, availability, expiry limitations, safety and cost, among others.